The outcome of prostate cancer screening in a normal Japanese population with PSA of 2-4 ng/ml and the free/total PSA under 12%.
OBJECTIVE
No previous study has reported the numbers of prostate cancer (PC) patients existing among a normal Japanese population with prostate-specific antigen (PSA) < 4 ng/ml. The aim of this study was to elucidate the performance of %free PSA as a screening tool for a normal Japanese population with PSA of 2-4 ng/ml and to examine the characteristics of cancer detected using this criterion.


METHODS
We conducted a prospective, multi-center study to evaluate the performance of %free PSA among a normal Japanese population. We decided on a %free PSA cutoff value of 12% according to the preliminary results. A total of 5548 consecutive screening volunteers aged 50-79 years were enrolled in the project. Men with total PSA > 4 ng/ml, or men with total PSA of 2-4 ng/ml and %free PSA of < or =12% were indicated to undergo 12 core biopsies.


RESULTS
There were 826 (14.9%) men with PSA of 2-4 ng/ml. Among them, those with %free PSA of < or =12% numbered 100 (12.1%). Forty-nine out of 100 men (49%) received biopsy, and 16 PC patients were detected. Among 10 patients undergoing radical prostatectomy, seven were associated with extra-prostatic extension (pT3) or high-grade cancer (Gleason score > or = 8).


CONCLUSIONS
We confirmed the ability of %free PSA and demonstrated that there are considerable numbers of PC patients among the normal Japanese population with PSA of 2-4 ng/ml. We ascertained that cancers detected in this study had a variety of tumor characteristics, including those of an aggressive nature.
Ishidoya
Shigeto
S
Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan. ishidoya@uro.med.tohoku.ac.jp
Ito
Akihiro
A
Orikasa
Kazuhiko
K
Kawamura
Sadafumi
S
Tochigi
Tatsuo
T
Kuwahara
Masaaki
M
Yamanobe
Takuya
T
Tomita
Yoshihiko
Y
Masumori
Naoya
N
Tsukamoto
Taiji
T
Shibuya
Daisuke
D
Arai
Yoichi
Y
D000368:Aged; D044466:Asian People / Q000706:statistics & numerical data*; D014408:Biomarkers, Tumor / Q000097:blood*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000453:epidemiology / Q000276:immunology* / Q000473:pathology; D012107:Research Design; D012680:Sensitivity and Specificity
D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen